Environmental risk assessment (ERA)
Environmental Risk Assessment (ERA) is a mandatory requirement for EMA submissions and global regulatory approvals. Companies often struggle to coordinate regulatory strategy, PEC calculations, Phase II testing, and PBT assessment across multiple partners.
We offer a true one-stop solution, combining regulatory ERA consulting with in-house ecotoxicology, biodegradability, and analytical testing capabilities.
Coordinated management of environmental studies, analytical support, ecotoxicology testing, and regulatory documentation within a single framework.
ERA testing strategy
Definition of a risk-based ERA testing strategy integrating Phase I screening, Phase II study planning, and alignment with EMA guidelines. Testing activities can be directly coordinated within the Eurofins laboratory network.
Gap analysis
Comprehensive review of available environmental data to identify missing endpoints, optimise testing requirements, and reduce unnecessary studies through scientifically justified waivers.
Tailored testing strategy
Tailored testing strategies for active substances with specific MoA (e.g., antibacterials and EAS) in line with ERA requirements. This includes selecting appropriate OECD aquatic ecotoxicity tests and ensuring full Phase II assessments, including fate studies, where triggered.
Environmental risk assessment documentation
Preparation and review of ERA modules including PEC calculation, risk characterisation, and regulatory scientific justification.
PBT evaluation
Assessment of persistence, bioaccumulation, and toxicity (PBT) properties supported by integrated ecotoxicological expertise.
PBT/vPvB assessment
Regulatory evaluation of PBT and very Persistent, very Bioaccumulative (vPvB) criteria supported by laboratory data and scientific interpretation.